In this study, the investigators would like to see if giving medroxyprogesterone acetate for 3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding, decrease the amount of nausea, bloating and cramping and increase patient satisfaction

Amount of bleeding with or without use of medroxyprogesterone acetate after initiation of gonadrotropin-releasing hormone agonist therapy, [ Time Frame: 30 days ] [ Designated as safety issue: No ]

The primary outcome of this study will be the amount of bleeding as measured by the validated Mansfield scale experienced by patients in the 28 days following the initiation of GnRHa therapy. This scale is from 0 (no bleeding) to 6 (very heavy bleeding or gushing). The patients will fill out this diary every day for 3 weeks after receiving GnRHa therapy.

Secondary Outcome Measures:

the number of days of bleeding, nausea, bloating, and pelvic pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]

2.2 Secondary outcomes will include the number of days of bleeding, nausea, bloating, and pelvic pain. These outcomes were set to evaluate efficacy of treatment (amount of bleeding, number of days of bleeding) as well as common side effects experienced with the medications being used (nausea, bloating, pelvic pain). The pelvic pain will be meausured based on a scale from 0 (none) to 10 (worst imaginable pain). Patient's nausea, bloating and breast tenderness is based on a scale from 0 (none) to 4 (severe).

If there is abnormal uterine bleeding, such bleeding is not obviously related to structural defects such as polyps or submucous leiomyomas; subserosal and intramural myomas (International Federation of Gynecology and Obstetrics Classification 3-8 inclusive) are acceptable

Exclusion Criteria:

Currently pregnant

Recent used of gonadrotropin-releasing hormone agonist

1 month depot formulation eg leuprolide acetate 3.75, within 90 days

3 month depot formulation eg leuprolide acetate 11.25 within 180 days

Currently has an intrauterine contraceptive device

Currently on gonadal steroids (including birth control pills, rings, or implantable or injectable agents)

History of breast cancer

Currently undergoing ovulation induction

History of adverse reactions to gonadal steroids

Hemoglobin <8 mg/dl as measured within 30 days of enrollment (Baseline hemoglobin is standard of care for patients initiating gonadrotropin-releasing hormone agonist therapy)

Weight above >250 lbs

Has a known submucous leiomyoma ( International Federation of Gynecology and Obstetrics Class type 0, 1, 2)

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776203